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Transformational Changes in Medical Device Regulations

Nicole Radziwill

New Medical Device Regulations emphasize robustness, transparency, predictability and sustainability, and were developed with technological advancements in mind.

In the March 2019 issue of Quality Progress, quality and regulatory consultant Kamala Kodihally Nanjundeshaiah summarizes the many updates that have taken place recently in medical device regulations.

These changes will continue to have strong and reverberating impacts through at least the end of 2020. ISO 13485:2016 is now:

  • The only viable standard that can be used for certification. Although it has not yet been updated to conform with the Annex SL high-level structure, changes from the 2003 revision do include an emphasis on risk-based thinking, customer satisfaction, and continuous improvement.
  • More flexible; some organizations can exclude clause 6 (training effectiveness), 7 (product realization) and 8 (remedial processes).
  • More concerned with traceability. Unique Device Identification (UDI) is now mandatory.


The European Union (EU) now exclusively relies on Medical Device Regulations (MDR) and In-vitro Diagnostics Regulations (IVDR) instead of 93/42, 90/385/EEC and 98/79/EC. The new regulations emphasize robustness, transparency, predictability, and sustainability, and were developed with technological advancements in mind. According to the EU, “The MDR combines the existing medical devices and active implantable medical devices directives.”

A new feature of these changes is the launch of the European Databank on Medical Devices (EUDAMED), which will keep track of device registration, certificate status, clinical investigations and post-market surveillance.

For a comprehensive look at the specific changes, and to see a process-based audit model that aligns with the FDA’s Medical Device Single Audit Program (MDSAP), please refer to the original article.

Additional Reading

Alouche, P. E. (2018, March 6). 3 Ways MDSAP Improves Audit Effectiveness. Intelex Blog. Available from

Freeman, G. (2018, October 5). Quality in the Medical Devices Industry. Intelex Blog. Available from

Nanjundeshaiah, K. K. (2019, March). Devising Change. Quality Progress. 52(3), p. 48-51. Available from

About the Author: Nicole Radziwill is the Vice President, Global Practice Leader, Quality & Supply Chain at Intelex Technologies. Before Intelex, she was an Associate Professor of Data Science and Production Systems, Assistant Director (VP) End-to-End Operations at the National Radio Astronomy Observatory (NRAO), and manager and consultant for several other organizations since the late 1990's bringing quality management to technologically-oriented operations. She is a Fellow of the American Society for Quality (ASQ) with a Ph.D. in Quality Systems from Indiana State University. Nicole serves as Editor of Software Quality Professional (SQP) journal and is a former Chair of the ASQ Software Division. She is an ASQ Certified Manager of Quality and Organizational Excellence (CMQ/OE) and Certified Six Sigma Black Belt (CSSBB). 



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May 09, 2019 @ 09:40 AM EDT Healthcare and Medical, Manufacturing Quality

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